Expired Study
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Indianapolis, Indiana 46202


Purpose:

The purpose of this study is to determine if haplotype-mismatched HSCT is associated with an improvement in treatment-related mortality (TRM) rate at 6 months.


Criteria:

Inclusion Criteria: - Patients must have histologically documented AML, ALL, MDS, CML, Acute myeloid leukemia (AML) with one or more of the following criteria - CR 1 with poor risk features - CR 2, or higher order CR - Acute lymphoblastic leukemia (ALL) with one of the following criteria - CR 1 with poor risk features - CR 2, or higher order CR - Myelodysplasia, RAEB I - Donor has been identified - Age ≤ 65 years. - Performance Status 0-1. Exclusion Criteria: - Patients relapsing <6 months after autologous SCT are not eligible. - Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection. - Non-pregnant and non-nursing


Study is Available At:


Original ID:

0704-19 IUCRO-0184


NCT ID:

NCT00593554


Secondary ID:


Study Acronym:


Brief Title:

Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies


Official Title:

A Phase II Trial of Haplotype Mismatched Hematopoietic Stem Cell Transplantation Using Highly Purified CD34 Cells in Patients With Hematological Malignancies


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Indiana University


Oversight Authority:

  • United States: Food and Drug Administration
  • United States: Institutional Review Board


Reasons Why Stopped:

Slow accrual


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

9


Enrollment Type:

Actual


Overall Contact Information

Official Name:Sherif Farag, MD/PhD
Principal Investigator
Indiana University School of Medicine

Study Dates

Start Date:August 7, 2007
Completion Date:July 28, 2017
Completion Type:Actual
Primary Completion Date:August 27, 2016
Primary Completion Type:Actual
Verification Date:March 2018
Last Changed Date:March 12, 2018
First Received Date:January 4, 2008
First Results Date:March 12, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Frequency of Infection
Time Frame:Day 0 through 1 year post transplantation
Safety Issues:False
Description:Number of unique patients with bacterial and/or viral infections reported.
Outcome Type:Secondary Outcome
Measure:Chronic Graft vs. Host Disease (GvHD)
Time Frame:Up to 1 year
Safety Issues:False
Description:Number of unique patients who had chronic Graft vs. Host Disease (GvHD) diagnosed while on the study.
Outcome Type:Secondary Outcome
Measure:Acute Graft vs. Host Disease (GvHD)
Time Frame:Up to 1 year
Safety Issues:False
Description:Number of unique patients who had acute Graft vs. Host Disease (GvHD) diagnosed while on the study.
Outcome Type:Secondary Outcome
Measure:Time to Platelet Engraftment
Time Frame:Transplant (Day 0) up to 1 year
Safety Issues:False
Description:Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive days after transplantation during which the platelet count is at least 20 x1
Outcome Type:Secondary Outcome
Measure:Time to Neutrophil Engraftment
Time Frame:Transplant (Day 0) up to 1 year
Safety Issues:False
Description:Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophil is defined as the time from transplant until absolute neutrophil count (ANC) > 500 uL for 3 consecutive days. The median and 95% confidenc
Outcome Type:Secondary Outcome
Measure:Regimen-related Toxicity
Time Frame:Up to 1 year
Safety Issues:False
Description:The number of unique patients who had adverse events that were possibly/probably/definitely related to treatment/regimen.
Outcome Type:Primary Outcome
Measure:Treatment-related Mortality (TRM) Rate at 6 Months After Transplantation
Time Frame:thru 6 months after transplant
Safety Issues:False
Description:To determine if haplotype-mismatched HSCT is associated with a ≤40% treatment-related mortality (TRM) rate at 6 months after transplantation; a TRM ≥60% being considered unacceptable. The percent of patients with the exact 95% confidence interval who had

Study Interventions

Intervention Type:Radiation
Name:Total Body Irradiation
Description:8 Gy on Day -9
Arm Name:1
Intervention Type:Drug
Name:Thiotepa
Description:5 mg/kg/d on Day -8 to -7
Arm Name:1
Intervention Type:Drug
Name:Fludarabine
Description:40 mg/m2/d on Day -6 to -3
Arm Name:1
Intervention Type:Biological
Name:Rabbit ATG
Description:2.5 mg/kg/d on Day -5 to -2
Arm Name:1
Other Name:Antithymocyte globulin
Intervention Type:Drug
Name:Palifermin
Description:60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
Arm Name:2
Other Name:Recombinant human keratinocyte growth factor

Study Arms

Study Arm Type:Active Comparator
Arm Name:1
Description:Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
Study Arm Type:Experimental
Arm Name:2
Description:Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Sherif S. Farag

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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